Microwave ablation combined with biopsy for diagnosing and treating ground-glass lung cancer

Study on the Diagnosis of Ground-glass Lung Cancer by Microwave Ablation Combined With Puncture Biopsy

This will try combining microwave ablation and puncture biopsy, guided by CT, AI and fragmentomics, to diagnose and treat people with small ground-glass lung nodules who cannot or choose not to have surgery.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Beidahuang Industry Group General Hospital (Academic / other)
• Locations: 1 site (Harbin, Heilongjiang)
• Trial ID: NCT06776588 on ClinicalTrials.gov

What this trial studies

The study plans to enroll 200 patients with ground-glass pulmonary nodules and collect detailed CT imaging and clinical features. AI-driven CT analysis and fragmentomics (circulating DNA fragment analysis) will be used alongside 3D CT reconstruction to estimate malignant risk. Participants will receive microwave ablation of the nodule with intraoperative rapid pathology of biopsy samples to judge tissue nature and ablation completeness. The trial aims to define optimal ablation time and power and will include long-term follow-up with CT surveillance and complication monitoring.

Who should consider this trial

Good fit: Adults age 75 or younger with ground-glass nodules ≤3 cm on lung-window CT who cannot or refuse surgical resection, have ECOG ≤2, and acceptable coagulation and platelet counts are ideal candidates.

Not a fit: Patients with nodules >3 cm, uncorrectable bleeding or severe organ dysfunction, advanced pulmonary disease, or very limited life expectancy are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could offer a less invasive way to diagnose and locally treat early ground-glass lung cancers while tailoring ablation settings to improve tumor control and reduce need for surgery.

How similar studies have performed: Percutaneous microwave ablation and image-guided biopsy are established for some lung nodules, but combining these with AI and fragmentomics to guide diagnosis and optimize ablation parameters is relatively novel with limited prior outcome data.

Eligibility criteria

Inclusion Criteria:

1. Age ≤ 75 years;
2. GGN patients with the maximum axial diameter of the lesion in the lung window ≤ 3 cm;
3. Refusing radical surgery or being unable to tolerate surgical treatment;
4. Normal coagulation function, platelet count ≥ 60 × 109 /L;
5. ECOG score ≤ 2 points;

Exclusion Criteria:

1. Patients with the maximum axial diameter of the lesion in the lung window greater than 3 cm
2. Platelets \<50×109 /L
3. Patients with severe bleeding tendency and coagulation dysfunction that cannot be corrected in the short term
4. Severe chronic obstructive pulmonary disease, emphysema, pulmonary fibrosis and pulmonary hypertension
5. Patients whose anticoagulant therapy or antiplatelet drugs have been discontinued for less than 5 days before ablation
6. Patients with severe heart, liver, kidney and brain dysfunction
7. Patients with severe anemia, dehydration and cachexia that cannot be corrected or improved in the short term
8. Patients with an estimated survival period of less than 6 months

Where this trial is running

Harbin, Heilongjiang

• Beidahuang Industry Group General Hospital — Harbin, Heilongjiang, China (Recruiting)

Study contacts

• Study coordinator: Mingyang Liu

Conditions Lung Cancer